Modular plate and cage elements and related methods

ABSTRACT

An interbody system for implanting between vertebrae, the interbody system comprises a cage having a cage body that includes a graft chamber having a volume that receives graft material, a sagittal wall that forms a portion of the graft chamber, and a wall membrane that forms another portion of the graft chamber. The interbody system may comprise an interbody device that includes an aperture that receives a bone fastener, wherein the wall membrane interacts with the bone fastener. The wall membrane may bend as result of a force applied by the bone fastener to a portion of the wall membrane, thereby providing directional support to the bone fastener and/or forcing graft material from the graft chamber.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to and benefit thereof from U.S.Provisional Patent Application No. 62/270,141, filed Dec. 21, 2015,titled “MODULAR PLATE AND CAGE ELEMENTS AND RELATED METHODS,” which ishereby incorporated herein by reference in its entirety.

FIELD OF THE DISCLOSURE

The present disclosure relates to intervertebral and intradiscalimplants and related systems and methods. More specifically, the presentdisclosure relates to intervertebral and intradiscal devices, systems,and methods for deployment within a body of a patient.

BACKGROUND OF THE DISCLOSURE

In mammals, the spinal (or vertebral) column is one of the mostimportant parts. The spinal column provides the main support necessaryfor mammals to stand, bend, and twist.

In humans, the spinal column is generally formed by individualinterlocking vertebrae, which are classified into five segments,including (from head to tail) a cervical segment (vertebrae C1-C7), athoracic segment (vertebrae T1-T12), a lumbar segment (vertebrae L1-L5),a sacrum segment (vertebrae S1-S5), and coccyx segment (vertebrateCo1-Co5). The cervical segment forms the neck, supports the head andneck, and allows for nodding, shaking and other movements of the head.The thoracic segment attaches to ribs to form the ribcage. The lumbarsegment carries most of the weight of the upper body and provides astable center of gravity during movement. The sacrum and coccyx make upthe back walls of the pelvis.

Intervertebral discs are located between each of the movable vertebra.Each intervertebral disc typically includes a thick outer layer calledthe disc annulus, which includes a crisscrossing fibrous structure, anda disc nucleus, which is a soft gel-like structure located at the centerof the disc. The intervertebral discs function to absorb force and allowfor pivotal movement of adjacent vertebra with respect to each other.

In the vertebral column, the vertebrae increase in size as they progressfrom the cervical segment to the sacrum segment, becoming smaller in thecoccyx. At maturity, the five sacral vertebrae typically fuse into onelarge bone, the sacrum, with no intervertebral discs. The last three tofive coccygeal vertebrae (typically four) form the coccyx (or tailbone).Like the sacrum, the coccyx does not have any intervertebral discs.

Each vertebra is an irregular bone that varies in size according to itsplacement in the spinal column, spinal loading, posture and pathology.While the basic configuration of vertebrae varies, every vertebra has abody that consists of a large anterior middle portion called the centrumand a posterior vertebral arch called the neural arch. The upper andlower surfaces of the vertebra body give attachment to intervertebraldiscs. The posterior part of a vertebra forms a vertebral arch thattypically consists of two pedicles, two laminae, and seven processes.The laminae give attachment to the ligament flava, and the pedicles havea shape that forms vertebral notches to form the intervertebral foraminawhen the vertebrae articulate. The foramina are the entry and exitpassageways for spinal nerves. The body of the vertebra and the verticalarch form the vertebral foramen, which is a large, central opening thataccommodates the spinal canal that encloses and protects the spinalcord.

The body of each vertebra is composed of cancellous bone that is coveredby a thin coating of cortical bone. The cancellous bone is a spongy typeof osseous tissue, and the cortical bone is a hard and dense type ofosseous tissue. The vertebral arch and processes have thicker coveringsof cortical bone.

The upper and lower surfaces of the vertebra body are flattened andrough. These surfaces are the vertebral endplates that are in directcontact with the intervertebral discs. The endplates are formed from athickened layer of cancellous bone, with the top layer being denser. Theendplates contain adjacent discs and evenly spread applied loads. Theendplates also provide anchorage for the collagen fibers of the disc.

FIG. 1 shows a portion of a patient's spinal column 2, includingvertebra 4 and intervertebral discs 6. As noted earlier, each disc 6forms a fibrocartilaginous joint between adjacent vertebrae 4 so as toallow relative movement between adjacent vertebrae 4. Beyond enablingrelative motion between adjacent vertebrae 4, each disc 6 acts as ashock absorber for the spinal column 2.

As noted earlier, each disc 6 comprises a fibrous exterior surroundingan inner gel-like center which cooperate to distribute pressure evenlyacross each disc 6, thereby preventing the development of stressconcentrations that might otherwise damage and/or impair vertebrae 4 ofspinal column 2. Discs 6 are, however, subject to various injuriesand/or disorders which may interfere with a disc's ability to adequatelydistribute pressure and protect vertebrae 4. For example, discherniation, degeneration, and infection of discs 6 may result ininsufficient disc thickness and/or support to absorb and/or distributeforces imparted to spinal column 2. Disc degeneration, for example, mayresult when the inner gel-like center begins to dehydrate, which mayresult in a degenerated disc 8 having decreased thickness. Thisdecreased thickness may limit the ability of degenerated disc 8 toabsorb shock which, if left untreated, may result in pain and/orvertebral injury.

While pain medication, physical therapy, and other non-operativeconditions may alleviate some symptoms, such interventions may not besufficient for every patient. Accordingly, various procedures have beendeveloped to surgically improve patient quality of life via abatement ofpain and/or discomfort. Such procedures may include, discectomy andfusion procedures, such as, for example, anterior cervical interbodyfusion (ACIF), anterior lumbar interbody fusion (ALIF), direct lateralinterbody fusion (DLIF) (also known as XLIF), posterior lumbar interbodyfusion (PLIF), and transforaminal lumbar interbody fusion (TLIF). Duringa discectomy, all or a portion of a damaged disc (for example,degenerated disc 8, shown in FIG. 1), is removed via an incision,typically under X-ray guidance.

Following the discectomy procedure, a medical professional may determinean appropriate size of an interbody device 9 (shown in FIG. 2) via oneor more distractors and/or trials of various sizes. Each trial and/ordistractor may be forcibly inserted between adjacent vertebrae 4. Upondetermination of an appropriate size, one or more of an ACIF, ALIF,DLIF, PLIF, and/or TLIF may be performed by placing an appropriateinterbody device 9 (such as, for example, a cage, a spacer, a block)between adjacent vertebrae 4 in the space formed by the removeddegenerated disc 8. Placement of such interbody devices 9 within spinalcolumn 2 may prevent spaces between adjacent vertebrae 4 fromcollapsing, thereby preventing adjacent vertebrae 4 from restingimmediately on top of one another and inducing fracture of vertebra 4,impingement of the spinal cord, and/or pain. Additionally, suchinterbody devices 9 may facilitate fusion between adjacent vertebrae 4by stabilizing adjacent vertebrae 4 relative to one another.Accordingly, as shown in FIG. 2, such interbody devices 9 often mayinclude one or more bone screws 11 extending through interbody device 9and into adjacent vertebrae 4.

Often, following the removal of the distractor and/or trial, a medicalprofessional must prepare one or more bores or holes in a vertebra 4intended to receive the bone screws 11. Such holes may be formed withthe aid of a separate drill guide positioned proximate or abuttingvertebra 4 and inserting a drill therethrough. Alternatively, such holesmay be formed free hand, without the use of a drill guide. Further,since spinal column 2 is subject to dynamic forces, often changing witheach slight movement of the patient, such screw(s) 11 have a tendency toback out (for example, unscrew) and/or dislodge from interbody device 9,thereby limiting interbody device's 9 ability to stabilize adjacentvertebrae 4, and consequently, promote fusion. Additionally, if screw(s)11 back out and/or dislodge from the interbody device 9, they mayinadvertently contact, damage, and/or irritate surrounding tissue.Further, interbody device 9 is commonly comprised of a radiopaquematerial so as to be visible in situ via x-ray and other similar imagingmodalities. However, such materials may impede sagittal and/or coronalvisibility, thereby preventing visual confirmation of placement andpost-operative fusion.

Thus, there remains a need for improved interbody devices, associatedsystems, and methodologies related thereto.

SUMMARY OF THE DISCLOSURE

The present disclosure includes examples that relate to, among otherthings, intradiscal, extradiscal, or interdiscal implants. The interbodydevices and systems (including, cages and/or plate devices) disclosedherein may be used as, for example, but not limited to, standalonedevices, anterior lumbar interbody fusion devices, standalone anteriorlow-profile plating devices, an interlocking of standalone devices tocreate hybrid devices, modular systems to allow interchangeability, andthe like. Each of the examples disclosed herein may include one or morefeatures described in connection with any of the other disclosedexamples.

According to an aspect of the disclosure, an interbody system isprovided for implanting between vertebrae. The interbody systemcomprises a cage having a cage body that includes a graft chamber havinga volume that receives graft material, a first sagittal wall having aninner wall surface that forms a first sagittal portion of the graftchamber, a second sagittal wall having an inner wall surface that formsa second sagittal portion of the graft chamber, an aft-wall having aninner wall surface that forms a posterior coronal portion of the graftchamber, and a wall membrane that forms an anterior coronal portion ofthe graft chamber. The interbody system may further comprise aninterbody device that includes an aperture that receives a bonefastener, wherein the wall membrane interacts with the bone fastener.

The wall membrane may interact with the bone fastener to bend as resultof a force applied by the bone fastener to a portion of the wallmembrane, thereby providing directional support to the bone fastener.

The wall membrane may interact with the bone fastener to bend as resultof a force applied by the bone fastener to reduce the volume of thegraft chamber, thereby forcing graft material from the graft chamber.

The wall membrane may comprise a slit. The slit may facilitate bendingof a portion of the wall membrane as a result of a force applied to saidportion of the wall membrane. The slit may receive and guide the bonefastener.

The wall membrane may comprise a thin sheet that is integrated with orattached to the cage body, a thin mesh that is integrated with orattached to the cage body, a thin screen that is integrated with orattached to the cage body, or a beams screen that is integrated with orattached to the cage body.

The sagittal wall of the cage body may comprise a recessed wall portionlocated proximate to the wall membrane. The sagittal wall may comprise agrip interface that contacts and engages a grip interface provided onthe interbody device to secure the cage to the interbody device.

The graft chamber may comprise a first chamber width portion that holdsgraft material, and a second chamber width portion that holds graftmaterial, wherein the width of the first chamber width portion isgreater than the width of the second chamber width portion.

The interbody interbody device may comprise two or more apertures thatreceive two or more respective bone screws.

The cage body may comprise a plate guide that engages a cage guideprovided on the interbody device to facilitate proper positioning andalignment of the cage with respect to the interbody device.

The cage body may comprise a plate engager that aligns with a cageengager provided on the interbody device to secure the cage body to theinterbody device.

According to a further aspect of the disclosure, an interbody system isprovided for implanting between vertebrae that comprises a cage bodyhaving a pair of sagittal walls, an aft-wall and a wall membrane that ismade of a shape memory form material. The interbody system may furthercomprise an interbody device that attaches to the cage body, wherein theinterbody device comprises an aperture that receives a bone fastener,and wherein the wall membrane bends under a force applied by the bonefastener.

According to a still further aspect of the disclosure, an interbodysystem is provided for implanting between vertebrae that comprises acage having a cage body that includes a graft chamber having a volumethat receives graft material, a sagittal wall that forms a portion ofthe graft chamber, and a wall membrane that forms another portion of thegraft chamber. The interbody system may further comprise an interbodydevice that includes an aperture that receives a bone fastener, whereinthe wall membrane interacts with the bone fastener.

Additional features, advantages, and embodiments of the disclosure maybe set forth or apparent from consideration of the detailed descriptionand drawings. Moreover, it is to be understood that both the foregoingsummary of the disclosure and the following detailed description areexemplary and intended to provide further explanation without limitingthe scope of the disclosure as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are included to provide a furtherunderstanding of the disclosure, are incorporated in and constitute apart of this specification, illustrate embodiments of the disclosure andtogether with the detailed description serve to help explain theprinciples of the disclosure. No attempt is made to show structuraldetails of the disclosure in more detail than may be necessary for afundamental understanding of the disclosure and the various ways inwhich it may be practiced. In the drawings:

FIG. 1 illustrates a portion of a patient's spinal column;

FIG. 2 illustrates an interbody device positioned within the patient'sspinal column;

FIG. 3 illustrates a perspective view of an example of a cage,constructed according to the principles of the disclosure;

FIG. 4 illustrates a perspective view of another example of a cage,constructed according to the principles of the disclosure;

FIGS. 5A-5F illustrate examples of cages, constructed according to theprinciples of the disclosure;

FIGS. 6A-6F illustrate further examples of cages, constructed accordingto the principles of the disclosure;

FIGS. 7A-7B illustrate different views of an example of a cage,constructed according the principles of the disclosure;

FIG. 8 illustrates and an example of an interbody system, constructedaccording to the principles of the disclosure;

FIGS. 9A-9C illustrate examples of a modular cage, constructed accordingto the principles of the disclosure;

FIG. 10 illustrates further examples of a modular cage, constructedaccording to the principles of the disclosure;

FIGS. 11A-11F show top views of examples of interbody devices,constructed according to the principles of the disclosure;

FIGS. 12A-12J illustrate examples of interbody devices, constructedaccording to the principles of the disclosure;

FIGS. 13A-13C illustrate different views of an example of a interbodydevice, constructed according to the principles of the disclosure;

FIG. 14 illustrates an example of the interbody device of FIGS. 13A-13Cinstalled between a pair of bony structures;

FIGS. 15A-15E illustrate different views of an interbody system thatincludes the cage of FIG. 4 and the interbody device of FIGS. 13A-13C;

FIGS. 16A-16C illustrate an example of the interbody system of FIGS.15A-15D installed between a pair of bony structures;

FIG. 17A illustrates a further example of an interbody device,constructed according to the principles of the disclosure;

FIGS. 17B-17E illustrate various views of an example of an interbodysystem that includes the plate device of FIG. 17A; and

FIGS. 18A-18C illustrate an example of the interbody system of FIGS.17B-17E installed between a pair of bony structures.

The present disclosure is further described in the detailed descriptionthat follows.

DETAILED DESCRIPTION OF THE DISCLOSURE

The disclosure and the various features and advantageous details thereofare explained more fully with reference to the non-limiting embodimentsand examples that are described and/or illustrated in the accompanyingdrawings and detailed in the following description. It should be notedthat the features illustrated in the drawings are not necessarily drawnto scale, and features of one embodiment may be employed with otherembodiments as the skilled artisan would recognize, even if notexplicitly stated herein. Descriptions of well-known components andprocessing techniques may be omitted so as to not unnecessarily obscurethe embodiments of the disclosure. The examples used herein are intendedmerely to facilitate an understanding of ways in which the disclosuremay be practiced and to further enable those of skill in the art topractice the embodiments of the disclosure. Accordingly, the examplesand embodiments herein should not be construed as limiting the scope ofthe disclosure. Moreover, it is noted that like reference numeralsrepresent similar parts throughout the several views of the drawings.

FIG. 3 illustrates an example of a cage (or interbody) device 101 thatis constructed according to the principles of the disclosure. The cage101 may include one or more features such as anti-migration and/oranchoring features, anti-rotation features, insertion tool features,reduced profile keel features, and the like. The cage 101 has a cagebody 110 that may be formed as a single piece, or that may be assembledfrom multiple pieces. The cage body 110 may have a trapezoidal shape forproper anterior placement. The cage 101 may be made of one or morematerials, including, for example, metal (e.g., titanium), metal alloy(e.g., titanium alloy), plastic, ceramic, elastomers, carbon fiberreinforced polymers, polyetheretherketone (PEEK), tricalcium phosphate,hyroxyaptaite, or the like, or any combination thereof. The cage 101 mayhave any shape, including, for example, a trapezoid, a square, arectangle, a circle, an ellipse, a semicircle, or the like, or anycombination of the foregoing, that may be implanted, for example,between a pair of adjacent vertebrae.

Referring to FIG. 3, the cage body 110 includes a pair of sagittal (orside) walls 141 and an aft-wall 142. The cage 101 may further include afore-wall 160. The sagittal walls 141, aft-wall 142 and fore-wall 160may form a chamber 150 that may receive and hold autologous bone,allograft bone, xenograft bone, bone graft material, osteoinductivematerial, blood, tissue, or the like. The chamber 150 may have a largegraft area to provide generous biological coverage. The inner surfacesof the sagittal walls 141, aft-wall 142 and/or fore-wall 160 may have asmooth surface or a pattern that may help in holding, for example, abone graft material in the chamber 150, such as, for example, aroughened surface, or a pattern that increases the coefficient offriction with respect to the bone graft material in the chamber 150. Oneor more of the outer surfaces of the side walls 141 and/or aft-wall 142may include a grip interface 143. The grip interface 143 may have apattern (e.g., teeth, serrations, protrusions, or the like) thatincreases gripability and improves handling by, for example, a surgeon'shand or instrument to securely grasp and hold the cage body 110 duringimplanting. The grip interface 143 may be configured to contact andengage a grip interface provided on an interbody device (for example,grip interface 2432 on the interbody device 240, shown in FIG. 13A), soas to secure the cage 101 to the interbody device.

The cage 101 may have a first surface 120 and a second surface 130. Thefirst surface 120 may include a plurality of bone interface members 121,such as, for example, teeth, serrations, protrusions, which may have ashape that is, e.g., triangular, pyramidal, conical, semispherical,rectangular, cylindrical, diamond, elliptical, and/or irregular shapes,or the like. The first and second surfaces 120, 130 may have anaggressive pattern formed by the bone interface members 121 to resistexpulsion. The first and second surfaces 120, 130, may be substantiallythe same or different. For instance, the first surface may include boneinterface members 121 that have, for example, a pyramidal pattern andthe second surface may include bone interface members (not shown) thathave, for example, a pyramidal pattern and/or a semi-spherical pattern.The bone interface members 121 engage with the bony surface of vertebralbodies in or near the treated area. The bone interface members 121 maybe formed integrally with the surface 120 (or 130) and may vary inprofile, distribution, size, and number. The configuration of thesurface 120 (or 130), including bone interface members 121, should besufficient to securely hold the cage 101 in the treated area aftersurgery while the treated area heals and undergoes fusion.

The fore-wall 160 may include a wall membrane 162, as seen in FIG. 3.The fore-wall 160 may include one or more slits 161. The slits 161 maybe formed in one or both of the superior or inferior directions (thatis, in the directions normal to the surfaces 120, 130). If the slits 161are formed in both the superior and inferior directions, then the slits161 may be offset from each other, so as to form a snake-like pattern(shown in FIG. 3). Alternatively (or additionally), the slits 161 may beformed so as to align with each other in the superior (or cranial) andinferior (or caudal) directions (shown in FIG. 4). The wall membrane 162may be made of a thin, flexible and/or malleable material. The wallmembrane 162 may be made of an elastic memory material that resumes adefault shape absent an external force, such as, for example, thedefault shape seen in FIG. 3 (or FIG. 4). The material may includetitanium, titanium alloy, PEEK, or the like. The fore-wall 160 may beconstructed so as to be easily poked, breached, bent or penetrated by,for example, a hole preparation instrument (not shown), a bone fastener,or the like.

The wall membrane 162 may function to deflect and guide a bone fastener11 to an anchoring position in the adjacent bone structure, as seen inFIGS. 15D and 16B, thereby facilitating easier and better positioning ofthe bone fastener 11 during installation of an interbody system (e.g.,interbody system 300 or 400, shown in FIGS. 15A-15E and 17B-17E). Forinstance, referring to FIGS. 15A and 15D, as a bone fastener 11 isinserted through an aperture 242, the distal end of the fastener 11 maycontact the wall membrane 162 and, as the fastener 11 is moved towardthe wall membrane 162, the upper (or lower) portion of the wall membranemay bend and deflect the fastener 11 upward (or downward) toward theanchor site on the adjacent vertebra 4 (shown in FIGS. 16B and 16C).

Further, when a graft material is located in the graft chamber 150,deflection of the bone fastener(s) 11 will result in portion(s) of thewall membrane 162 moving into the graft chamber 150 and reducing thespace in the chamber 150, thereby, forcing graft material upward and/ordownward out of the graft chamber 150 and into the spaces surroundingthe cage 101, including packing the graft material into the area betweenthe cage 101 and adjacent vertebrae 4 to better promote bone growth.

The cage 101 may include one or more radiopaque elements 170 to assistwith alignment, positioning or placement of the cage 101 in a treatedarea. The radiopaque element(s) 170 may include, for example, aradiopaque tantalum bead, or the like. The cage 101 may be provided withone radiopaque element 170 at each of three corners of the cage 101 tofacilitate radiographic implant positioning.

The cage 101 may include one or more plate interfaces 163. The plateinterface 163 may be integrally formed with the cage body 110. The plateinterface 163 may be constructed as an extension of the side wall 141.The plate interface 163 may be configured to correspond to and mate with(or engage) a corresponding cage interface (e.g., cage interface 2463,shown in FIG. 13C) provided on an interbody device (e.g., interbodydevice 240 shown in FIGS. 13A-13C). When mated to the cage interface,the plate interface 163 may provide a secure and snug fit, so as toproperly align the interbody device and cage 101 with respect to eachother. The plate interface 163 and cage interface (e.g., cage interface2463, shown in FIG. 13C) may be constructed as a tongue and grooveconfiguration, with one of the interfaces being formed as the tongueportion and the other interface being formed as the groove portion.

FIG. 4 illustrates a perspective view of another example of a cage (orinterbody) device 102, constructed according to the principles of thedisclosure. The cage 102 includes a cage body 110. The cage body 110includes a pair of sagittal (or side) walls 141 and the aft-wall 142.The cage 102 further includes the fore-wall 160. The side walls 141 mayinclude a pair of recessed wall portions 144 located near the fore-wall160. The inner surfaces of the side walls 141, the aft-wall 142 andfore-wall 160 form the graft chamber 150. The cage 102 may be made ofone or more materials, including, for example, metal (e.g., titanium),metal alloy (e.g., titanium alloy), plastic, ceramic, elastomers, carbonfiber reinforced polymers, polyetheretherketone (PEEK), tricalciumphosphate, hyroxyapaite, or the like, or any combination thereof.

The graft chamber 150 may include a chamber-width portion 152 and achamber-width portion 154. The width the of the chamber-width portion152 may be less than the width of the chamber-width portion 154.Alternatively, the width of the camber-width portion 152 may be equal toor greater than the width of the chamber width portion 154. Thechamber-width portion 152 may have a width formed between opposing innerwall surfaces of the side walls 141 by the inner wall surface of a plateinterface region 144 on each of the side walls 141.

The plate interface region 144 of the side wall 141 may include the gripinterface 143 and a plate guide 146. The wall plate interface region 144may include a plate engager 147.

The plate guide 146 may be formed as, for example, a longitudinal trackalong the longitudinal axis of the side wall 141. The plate guide 146may be configured to engage a corresponding cage guide (e.g., cage guide2433, shown in FIGS. 13A, 13C) provided on an interbody device (e.g.,interbody device 240, shown in FIGS. 13A, 13C), so as to facilitateproper positioning and alignment of the cage 102 with respect to theinterbody device (e.g., interbody device 240 shown in FIGS. 13A-13C orinterbody device 410 shown in FIGS. 17A-17E).

The plate engager 147 may be formed as an aperture (e.g., asemi-spherical recess, a dented-in portion, an opening that extends fromthe outer surface to the inner surface of the wall 141, or the like) oras a protrusion (e.g., a semi-spherical bump, or the like). The plateengager 147 may be positioned and configured to align with a cageengager on an interbody device (e.g., cage engager 2431 on interbodydevice 240, shown in FIG. 13A).

As seen in FIGS. 3 and 4, the wall membrane 162 may be formed integrallyas part of the cage, or the wall member 162 may be attached to ends ofthe walls 140 (shown in FIGS. 5A-5E).

FIGS. 5A-5F illustrate examples of cages with different wall membranes162, constructed according to the principles of the disclosure. As seen,FIG. 5A illustrates an example with the wall member 162 formed as a thinsheet that may be integrated with a cage body 27; FIG. 5B illustrates anexample of the wall membrane 162 formed as a thin mesh, which may beintegrated with or attached to the cage body 27; FIG. 5C illustrates anexample of the wall membrane 162 formed as a thin screen, which may beintegrated with or attached to the cage body 27; FIG. 5D illustrates anexample of the wall membrane 162 that may be formed as a beams screen,which may be integrated with or attached to the cage body 27; FIG. 5Eillustrates an example of attaching the wall membrane 162 by aligningand inserting ends of the wall member 162 into corresponding receivertracks 149 that may be formed in the inner sides of the walls 141; and,FIG. 5F illustrates an example where the wall membrane 162 does notinteract with bone fastener(s). The cage body 27 may be substantiallythe same as the cage body 110 (shown in FIG. 3 or 4).

FIGS. 6A-6F illustrate further examples of cages, constructed accordingto the principles of the disclosure, which may be used to reduceinventory by providing a cage that may adjust angle of lordosis. As seenin the illustrations, the cage may include the cage body 27 with anangle adjustment system, which may include an angle adjustment slit 1412formed longitudinally in the side walls 141 and aft-wall 142, and anangle adjustment insert 1413 (shown in FIGS. 6A-6E), or an angleadjustment hinge 1417 (shown in FIG. 6F). The cage body 27 may be madeof a material, such as, for example, a shape memory material thatreverts to a particular configuration in the absence of any externalforce (shown in FIG. 6C).

Referring to FIG. 6A, the cage body 27 may be formed with an angleadjustment slit 1412 in each of the side walls 141 and the aft-wall 142.The angle adjustment slit 1412 may be formed longitudinally along thelongitudinal axis of the side wall 141 and the aft-wall 142, therebyseparating the cage body 27 into a superior cage body portion 1421 andan inferior cage body portion 1422. The end portions of the superiorcage body portion 1421 and the inferior cage body portion 1422 that areformed by the aft-wall 142 are configured to move toward or away fromeach other, thereby allowing for adjustment of angle of lordosis. Theadjustment angle θ (shown in FIG. 6E) may be defined and adjusted by,for example, inserting (or removing) the adjustment insert 1413 in oneor both of the angle adjustment slits 1412. The adjustment angle may bevaried and set by moving (e.g., incrementally) the adjustment insert1413 along the angle adjustment slit(s) 1412.

The angle adjustment slit(s) 1412 may have a substantially uniform widthalong its entire length, or the width may vary along the length of theangle adjustment slit 1412 (e.g., increasing or decreasing). Theadjustment insert 1413 may include, for example, a rod, a block, or anyother shape without departing from the scope or spirit of thedisclosure. The diameter or height of the adjustment insert 1413 mayvary to provide varying angles of adjustment. The length of theadjustment insert 1413 may vary depending on the dimensions of the cagebody 27. The cage body 27 may include a fulcrum aperture 1411, which mayprovide added flexibility to the cage body 27 with angle adjustmentslits 1412. The fulcrum aperture 1411 may have a diameter (or width)that is greater than the width of the portion of the angle adjustmentslit 1412 nearest to the fulcrum aperture 1411.

FIG. 6B shows the cage body 27 provided with flexing cutouts 1414 aboveand/or below the fulcrum aperture 1411. The flexing cutouts 1414 areformed to provide added flexibility to the cage body 27 with respect tothe cage body portions 1421, 1422. The portion of the adjustment slit1412 in the aft-wall 142 may include tapered wall portions 1415, so asto facilitate easier installation of the adjustment insert 1413 into theadjustment slit 1412.

FIG. 6C shows the cage body 27 with the adjustment insert 1413 removedfrom the adjustment slit 1412. In this example, the cage body 27 isformed of a memory-form material that reverts to a maximum adjustmentangle θ in the absence of an external force. The angle θ may be adjustedby inserting the adjusting insert 1413 into the adjustment slit 1412. Inthis regard, the cage body 27 may include the tapered wall portions 1415so as to facilitate easier insertion of the adjusting insert 1413 intothe adjustment slit 1412.

FIGS. 6D and 6E illustrate examples of the cage body 27 provided with aninsert lock 1416. As seen, the insert lock 1416 may be a notch, such as,for example, a notch formed longitudinally along the adjustment slit inthe aft-wall 142. The notch may be formed longitudinally in the aft-wall142 and/or transversely across the side wall(s) 141 (i.e., across thewidth of one or both side walls 141). The notch may have a shape suchas, for example, a semi-circle, a square, a rectangle, or the like. Thenotch may be formed in either or both of the superior and inferior bodyportions 1421, 1422. The insert lock 1416 may have a height (ordiameter) that is substantially equal to the height (or diameter) of theadjustment insert 1413. Alternatively, the height (or diameter) of theinsert lock 1416 may be greater or less than the height (diameter) ofthe adjustment insert 1413. The insert lock 1416 may function tosecurely hold the adjustment insert 1413, so as to provide apredetermined adjustment angle θ. Although not shown, the adjustmentslit 1412 may be provided with a plurality of insert locks 1416 alongthe length of the slit, each of which may be formed to provide adifferent, predetermined adjustment angle θ, which may be determined bythe location of the insert lock 1416 along the adjustment slit, theheight (or diameter) of the insert lock 1412, or the shape of the insertlock 1412.

FIG. 6F shows an example of a cage body 27 provided with a hinge 1417.As seen, the superior cage body portion 1421 and the inferior cage bodyportion 1422 may be connected by a hinge 1417 provided in the cage body27 at the end opposite the aft-wall 142. The hinge 1417 is configured topermit one or both of the cage body portions 1421, 1422 to pivot towardor away from each other, thereby adjusting the angle θ.

FIGS. 7A-7B illustrate different views of a cage body provided with apair of anchor rims 121, 122. Although shown with two anchor rims 121,122, the cage body may be provided with only a single anchor rim 121 (or122) provided on one of the superior or inferior surfaces of the cagebody. Alternatively (or additionally), a plurality of anchor rims 121(or 122) may be provided on the same surface of the cage body. Theanchor rim 121 (or 122) may be continuous (shown in FIG. 7A) ordiscontinuous (not shown, such as, e.g., in one or more segments). Theanchor rim 121 (or 122) may have a consistent geometry (shown in FIG.7A) or have a variable geometry (shown in FIG. 7B). The geometry may be,for example, a serrated pattern, a saw-tooth pattern, or any otherpattern that may aggressively contact and engage boney matter

FIG. 8 illustrates an example of an interbody system, constructedaccording to the principles of the disclosure. The interbody system mayinclude the cage body 27 and an interbody (or plate) device 1600. Theinterbody system may further include a wall membrane 162 (not shown),which may be positioned at, for example, the anterior portion of thecage body 27, and proximate the inner wall surface of the interbodydevice 1600. The interbody device 1600 may be attached to the cage body27 by an attachment mechanism, such as, for example, a bonding oradhesive material, a pressure fit, tongue and groove, spring clamp,joining screws, or the like.

The interbody system of FIG. 8 is an example of a pressure fitattachment mechanism, which includes one or more receivers (e.g.,openings) 1612 provided on the cage body 27, and corresponding one ormore protrusions 1611 on the interbody device 1600. Alternatively, theone or more receivers 1612 may be provided on the interbody device 1600and the corresponding one or more protrusions 1611 may be provided onthe cage body 27. As seen, the receivers 1612 may be formed to alignwith and securely receive the corresponding protrusions 1611 when theinterbody device 1600 and cage body 27 are pressed toward each other, soas to securely fasten the interbody device 1600 to the cage body 27.

FIGS. 9A-9C illustrate examples of a modular cage system 210,constructed according to the principles of the disclosure. Theshell-in-shell configuration of the modular cage system 210 can be usedto minimize inventory of parts. The modular cage system 210 provides anadjustable footprint, wherein a closed loop geometry may be implemented(shown in FIGS. 9A-9 b), an open loop geometry may be implemented (notshown), or a hybrid closed-open loop geometry may be implemented (shownin FIG. 9C).

Referring to FIGS. 9A-9B, the modular cage system 210 comprises aplurality of closed loop cage bodies 212, 214, 216, 218. Each of thecage bodies 212, 214, 216, 218, may have substantially the same shapeand varying (e.g., increasing or decreasing) size (e.g., height, width,length, surface angle (e.g., angle of superior surface alongposterior-anterior and/or lateral directions of cage body, and/or angleof inferior surface along posterior-anterior and/or lateral directionsof cage body)), so that the cage bodies may be nested together to form aunitary configuration of the modular cage system 210, as seen in FIG.9B, by nesting one inside another. One or more of the cage bodies 212,214, 216, 218 may have a different shape and/or size than the other cagebodies. The cage bodies may be selected and nested together to form acage system 210 that matches the size, shape, contours, etc. of theadjacent vertebrae surfaces. Each of the cage bodies 212, 214, 216, 218may be made of a single material or combination of various materialsfor, for example, radio-opaque and/or strength effects. The cage bodies212, 214, 216, 218 may be made of the same or different materials. Themodular cage system 210 may include, for example, two, three, four, ormore cage bodies.

The cage bodies 212, 214, 216, 218 each have a graft chamber GC, whosedimensions and position may be varied by varying the thicknesses and/orshapes of the walls of the respective cage body. For instance, by makingone of the four walls of the cage body 212 much thicker than the otherthree walls, the center of the graft chamber GC may be shifted away fromthe thicker wall. Further, by altering the inner contours of the wallsof a cage body, the shape of the graft chamber GC may be selectivelydetermined. The outer contours of the walls of one or more of the cagebodies 212, 214, 216, 218 may be varied to form cage bodies based on theparticular anatomy of a patient.

Referring to FIG. 9C, a hybrid modular cage system 219 comprises a pairof open loop cage bodies 215, 217 nested in the closed loop cage body218. The open loop cage bodies 215, 217 may each be formed with threewalls, as seen in the illustration. Each of the cage bodies 215, 217,may have substantially the same shape and increasing (or decreasing)size, so that the cage bodies may be nested together to form a unitaryconfiguration of the modular cage system 219, as seen in FIG. 9C, bynesting one inside another. The cage body 218 may have substantially thesame (or different) shape as the open loop cage body 215 and/or 217, soas to receive and hold each of the cage bodies 215, 217 in the graftchamber GC of the cage body 218. One or more of the cage bodies 215,217, 218 may have a different shape than the other cage bodies. Each ofthe cage bodies 215, 217, 218 may be made of a single material orcombination of various materials for, for example, radio-opaque and/orstrength effects. The cage bodies 215, 217, 218 may be made of the sameor different materials.

One or more of the cage bodies 215, 217 may be nested in the cage body218 to modify the dimensions, position and/or shape of the graft chamberGC in the cage body 218. By selecting wall dimensions and shapes of eachof the cage bodies 215, 217, and nesting the cage bodies 215, 217 in apredetermined direction, the dimensions, position and/or shape of thegraft chamber GC may be selectively determined. The predetermineddirection may comprise, for example, the open end of the cage body 215facing in the same or a different direction than the open end of thecage body 217. As seen in FIG. 9C, the open ends of the cage bodies 215,217 may be positioned in the same direction, so as to position thecenter of the graft chamber GC toward the open end of the cage bodies215, 217, when nested in the configuration seen in FIG. 9C. By makingone of the walls of a cage body much thicker than the other three walls,the center of the graft chamber GC may be shifted away from the thickerwall. Further, by altering the inner contours of the walls of a cagebody, the shape of the graft chamber GC may be selectively determined.The outer contours of the walls of one or more of the cage bodies 215,217, 218 may be varied to form cage bodies based on the particularanatomy of a patient.

FIG. 10 illustrates an example of modular cage system 220, constructedaccording to the principles of the disclosure. The modular cage system220 may comprise a plurality of closed loop cage bodies 224A, 224B,224C. The modular cage system 220 may, instead, include all open loopcage bodies (not shown), or a hybrid system of open and closed loop cagebodies (not shown). The modular cage system 220 may further include oneor more end caps 221A, 221B, 225. Each of the cage bodies 224A, 224B,224C, may have substantially the same shape with varying (e.g.,increasing or decreasing) size (e.g., height, width, length, surfaceangle (e.g., angle of superior surface along posterior-anterior and/orlateral directions of cage body, and/or angle of inferior surface alongposterior-anterior and/or lateral directions of cage body)), as seen inFIG. 10, so that the cage bodies 224A, 224B, 224C may be interchangeablyused with one or more of the end caps 221A, 221B, 225. One or more ofthe cage bodies 224A, 224B, 224C may have a different shape than theother cage bodies. Each of the cage bodies 224A, 224B, 224C and/or theend caps 221A, 221B, 225 may be made of a single material or combinationof various materials for, for example, radio-opaque and/or strengtheffects. The cage bodies 224A, 224B, 224C and/or the end caps 221A,221B, 225 may be made of the same or different materials.

The cage bodies 224A, 224B, 224C may have any shape that may beimplemented in an application between vertebral bodies, as will beunderstood by those skilled in the art. For instance, the cage bodies224A, 224B, 224C may have a trapezoidal shape, with the side wallstapered inward in the posterior direction (e.g., shape of cage body 102shown in FIG. 4), or the shape of the cage bodies 224A, 224B, 224C maybe a square, rectangular, elliptical, circular, semicircular, or thelike. The end caps 221A, 221B, 225 may have a shape that matches theshape of the cage bodies 224A, 224B, 224C.

As seen in FIG. 10, the end caps 221A, 221B, 225 may each include aninsert portion 223A, 223B, 226, respectively, and/or a rim portion 222A,222B, 227, respectively. For instance, referring to the end cap 221Awith the understanding that the description equally applies to the endcaps 221B and 225, the end cap 221A includes an insert portion 223A thatmay be inserted into the opening of the cage body 224A (or 224B or224C), and a rim portion 222A that may function as a stop and/or cap forthe cage body 224A (or 224B or 224C). The thickness, size and/or shapeof the wall portions that form the insert portion 223A may bepredetermined so as to selectively determine the position, shape, and/orsize of the graft chamber in the cage body 224A (or 224B or 224C). Forinstance, the walls of the insert portion 223A may be varied in terms ofsize and shape, including, for example, height, width, length, surfaceangles, so as to determine the shape, position and size of the graftchamber in the cage body 224A (or 224B or 224C) when the end cap 221A isattached to the cage body 224A.

Similarly, the thickness, size and/or shape of the rim portion 222A maybe varied to, for example, match anatomical requirements for particularapplications of the cage system. For instance the height of the wallsthat form the rim portion 222A may be decreased (or increased) in theposterior (or anterior) direction, so as to provide better fit invertebral interbody applications. The rim portion 222A may be configuredto contact and engage a vertebral body. In this regard, the surface ofthe rim portion 222A may be contoured to match the shape of thevertebral body. The surface may include bone interface members (e.g.,bone interface members 121, shown in FIG. 3) that may be configured toaggressively grip against the bony surface of the adjacent vertebralbody (e.g., vertebral body 4, shown in FIG. 2).

FIGS. 11A-11F show superior/cranial (or inferior/caudal) views ofexamples of interbody devices 230A-230F, respectively, constructedaccording to the principles of the disclosure. More specifically, FIG.11A illustrates the superior or cranial (or inferior or caudal) view ofinterbody device 230A that may be substantially planar, having ananterior surface (not shown) and a posterior surface (not shown) withdimensions that are significantly greater than any one of the wallsurfaces, including the superior (or inferior) surface (shown in FIG.11A), and sagittal (or side) surfaces (not shown); FIG. 11B illustratesthe superior (or inferior) view of interbody device 230B that has aC-shape (see also perspective views of examples of C-shape interbodydevices in FIGS. 12A-12C) in the transverse plane; FIG. 11C illustratesthe superior (or inferior) view of interbody device 230C that has aC-offset shape in the transverse plane; FIG. 11D illustrates thesuperior (or inferior) view of interbody device 230D that has aquadrilateral shape (see also perspective views of examples of trapezoidshape interbody devices in FIGS. 12D-12G) in the transverse plane; FIG.11E illustrates the superior (or inferior) view of interbody device 230Ethat has a quadrilateral offset shape in the transverse plane; and FIG.11F illustrates the superior (or inferior) view of an I-beam shapeinterbody device 230F in the transverse plane.

FIGS. 12A-12J illustrate perspective views of examples of interbodydevices 240A-240J, respectively, constructed according to the principlesof the disclosure. More specifically, FIGS. 12A-12C illustrateperspective views of examples of C-shape interbody devices 240A-240C,respectively; FIGS. 12D-12G illustrate perspective views of examples oftransverse plane quadrilateral shape interbody devices 240D-240G,respectively; and FIGS. 12H-12J illustrate perspective views of examplesof lateral I-beam shape interbody devices 240H-240J, respectively.

Referring to FIG. 12A, interbody device 240A may include a face 241defining two apertures 242. The interbody device 240A may include alocking element 247, which is described in detail below. Variousarrangements of interbody devices 240A may include one or more featuresconfigured to facilitate sagittal and/or coronal visibility. Forexample, a body or frame 243 of interbody device 240A may comprise aradiopaque material visible via x-ray or similar forms of imagingmodalities. As such, frame 243 may enable accurate positioning and/orplacement of interbody device 240A within and/or along spinal column 2(shown in FIG. 1). Frame 243 may include any one or more features suchas anti-migration and/or anchoring features, anti-rotation features,insertion tool features, reduced profile keel features, and the like.Additionally, frame 243 may define one or more openings and/or windows244. Such windows 244 may remain empty and/or may be filled withradiolucent material such as tissue grafts as will be described infurther detail below. Window(s) 244 may enable a medical professional toview and/or determine the level of post-operative fusion betweeninterbody device 240A and patient bone and/or tissue. Frame 243 maydefine any appropriate arrangement, number, and configuration ofwindow(s) 244. That is, as shown in FIG. 12A, for example, interbodydevice 240A may comprise a standalone device having an open cage, or theinterbody device 240A may be used as a plate device and attached to acage (not shown). As shown in FIG. 12A, frame 243 may include a singlewindow 244 on each lateral side. Each window 243 may be generallyquadrilateral (e.g., square, rectangular, or trapezoidal). In somearrangements, a radiolucent structure, such as a graft containmentsheath, may be disposed along one or more portions of frame 243. Indeed,such graft containment sheaths may substantially fill or encompasswindow 244 of one or more sides of frame 243. Accordingly, when theinterbody device 240A is placed between two adjacent vertebrae 4 (shownin FIG. 1) under X-ray vision, window 244 remains radiolucent such thatfusion within and/or through window 244 may be observed. In anotherarrangement, the interbody device 240B may comprise a standalone devicehaving an open cage as seen in FIG. 12B, or it may be combined with acage body (not shown), such as, for example the cage body 10 shown inFIG. 62 of U.S. patent application Ser. No. 14/956,084, filed Dec. 1,2015, titled “Intervertebral Implants and Related Systems and Methods,”the entirety of which is incorporated herein by reference.

Referring to FIGS. 12A and 12C, the interbody device 240C may have asimilar arrangement to the interbody device 240A, except that thewindow(s) 244 may be open on the posterior end, as seen in FIG. 12C.

Referring to FIGS. 12D and 12G, the interbody devices 240D and 240G maybe substantially the same as the devices 10 shown in FIGS. 33 and 35,respectively, in U.S. patent application Ser. No. 14/956,084, filed Dec.1, 2015, titled “Intervertebral Implants and Related Systems andMethods,” which has been incorporated herein by reference.

FIGS. 12E-12F examples of interbody devices 240E and 240F that haveI-beam shape and a C-shape, respectively, in the sagittal plane. Bothdevices 240E and 240F have a closed trapezoidal shape frame 243 in thetransverse plane.

FIGS. 12H-12J illustrate perspective views of examples of interbodydevices 240H-240J that have an I-beam shape in the transverse plane, butvarying arrangements in the sagittal plane. For instance, the interbodydevice 240H includes a frame 243 that has substantially quadrilateral(e.g., trapezoidal, rectangular, or the like) closed shape in thesagittal plane, which may include a window 244. The interbody device240I includes a frame 243 that is substantially a rectangular rod inboth the transverse and sagittal planes. The interbody device 240Jincludes a frame 243 that has a C-shape in the sagittal plane, includingan open-ended window 244.

FIGS. 13A-13C illustrate different views of an example of an interbodydevice 240 that is constructed according to the principles of thedisclosure, including a perspective front or anterior view (FIG. 13A), afront or anterior view (FIG. 13B), and a perspective back or posteriorview (FIG. 13C).

Referring to FIGS. 13A-13C, the interbody device 240 may include theanterior or front coronal face 241 and a posterior or back coronal face248 (shown in FIG. 13C) defining a plurality (e.g., two) apertures 242therebetween. The interbody device 240 may include a locking element247. The interbody device 240 may be formed as a single piece (notshown), or it may be assembled from two or more pieces, such as, forexample the frame 243 and the locking element 247.

The aperture(s) 242 may have an angled opening so as to better guide afastener 11 (shown in FIG. 14) as it is inserted in and through theaperture 242 into adjacent bone, thereby securing the fastener 11 inadjacent vertebra (shown in FIG. 14) in, for example, an optimal anglefor securing the interbody device 240 to the vertebrae 4.

The locking element 247 may be similar in construction and manner of useas described, for example, in FIG. 3A-22D, 33, 35, 37, 39, 55, 58-65B,or 69A-78E and the corresponding text in U.S. patent application Ser.No. 14/956,084, filed Dec. 1, 2015, titled “Intervertebral Implants andRelated Systems and Methods,” which has been incorporated herein byreference. Further, various arrangements of interbody devices 240 mayinclude one or more features configured to facilitate sagittal and/orcoronal visibility. For example, the body or frame 243 of interbodydevice 240 may comprise a radiopaque material visible via x-ray orsimilar forms of imaging modalities. As such, frame 243 may enableaccurate positioning and/or placement of interbody device 240 withinand/or along spinal column 2 (shown in FIG. 1). Frame 243 may includeany one or more features such as anti-migration and/or anchoringfeatures, anti-rotation features, insertion tool features, reducedprofile keel features, and the like, as will be described in furtherdetail below.

For instance, the frame 243 may include anti-migration and/or anchoringfeatures 2432, 246. The features 2432 may be configured to contact andengage surface portions of, for example, a cage 102 (or 101) (shown inFIGS. 15A-15D) to secure the interbody device 240 to the cage 102. Thefeatures 2432 may be configured to assist in aligning and properpositioning of the interbody device 240 with respect to the cage 102 (or101).

The anti-migration and/or anchoring features 246 may be located on upperand/or lower surfaces of the interbody device 240 that contact bonesurface(s).

The features 2432 and/or 246 may comprise, for example, a pattern and/ortexture that provides anti-migration and/or anchoring characteristicswhen implanted in the spine 2. The features 2432 and/or 246 maycomprise, e.g., teeth, serrations, protrusions (e.g., triangular,pyramidal, conical, semi spherical, rectangular, cylindrical, diamond,elliptical, and/or irregular shapes, or the like), or the like.

The frame 243 may include a channel 2433, as seen in FIGS. 13A and 13C.The channel 2433 may be provided on one or both inner walls of the frame243. The channel 2433 may be configured to receive, engage and guide aplate guide of, for example, a cage 102 (e.g., plate guide 146 of cage102, shown in FIG. 4), thereby providing proper alignment andpositioning of the interbody device 240 with respect to the cage 102(e.g., as seen in FIGS. 15A-15D).

Alternatively, the frame 243 may include a guide element (not shown),such as, for example, the plate guide 146 (shown in FIG. 4), that isconfigured to be received, engaged, and guided by a channel (not shown)that may be provided in the cage body.

The interbody device 240 may further include an engager element 2431.The engager element 2431 may be positioned and configured to align withand engage a plate engager, such as, for example, the plate engager 147(shown in FIG. 4) to secure the interbody device 240 into final positionwith respect to the cage body (e.g., shown in FIGS. 15A-15C). Theengager element 2431 may be arranged as a male element such as aprotrusion, or the like, provided on an inner wall of the frame 243, ora female element such as a recess provided in the inner wall of theframe 243, or an opening formed through the wall of the frame 243, orthe like. In this regard, the plate engager (e.g., plate engager 147,shown in FIG. 4) may include an oppositely configured element thatengages and mates with the engager element 2431 to secure the cage(e.g., cage 102 shown in FIGS. 15A-15D) to the interbody device 240.

Referring to FIGS. 13A-13C and 14 simultaneously, the interbody device240 may be configured for use in, for example, anterior approach anddisectomy applications. For instance, after a patient is positioned in asupine position on, for example, a radiolucent operating table, thesurgical area cleaned, an incision made, muscle tissue and/or organsmoved to the side(s), and other common surgical procedures carried out,a disc may be incised, removed, and the space prepared for implanting ofan interbody device 240. The bone surfaces and edges on the adjacentvertebrae 4 may be carefully contoured, as appropriate.

Following a discectomy procedure, a medical professional may determinean appropriate size of the interbody device 240 by selecting anappropriately dimensioned interbody device 240, which may be selectablebased on, for example, height, width, depth, surface angle(s), and thelike. Upon selecting the appropriate interbody device 240, one or moreof an ACIF, ALIF, or the like may be performed by placing the interbodydevice 240 between adjacent vertebrae 4 in the space formed by theremoved degenerated disc (shown in FIG. 14). One or more fasteners 11may be installed using an instrument (not shown), such as, for example,a screw driver (not shown). The locking element 247 may then be turnedor otherwise manipulated to secure the fasteners 11 in place, therebypreventing the fasteners 11 from loosening or withdrawing from the bone.

Placement of the interbody device 240 within spinal column may preventspaces between adjacent vertebrae 4 from collapsing, thereby preventingadjacent vertebrae from resting immediately on top of one another andinducing fracture of vertebra 4, impingement of the spinal cord, and/orpain. Additionally, such interbody device 240 may facilitate fusion(e.g., bone to grow together) between adjacent vertebrae 4 bystabilizing adjacent vertebrae 4 relative to one another.

FIGS. 15A-15E illustrate different views of an interbody system 300 thatincludes the interbody device 240 and the cage 102 (or 101, shown inFIGS. 3 and 4). The interbody system 300 may be formed as a singlestructure (not shown), or it may be assembled from two or more pieces.

For instance, referring to FIG. 15E, the interbody system 300 may beassembled by attaching the interbody device 240 to the cage 102 (or101). In this regard, the interbody 240 may be positioned so that thechannels 2433 are aligned with corresponding plate guides 146 on thecage 102, as seen in FIG. 15E. The interbody device 240 and cage 102 maythen be moved toward each other, with the plate guides 146 beingreceived and guided by the respective channels 2433 as the cage 102moves toward the back face 248 (shown in FIG. 13C) of the interbodydevice 240, until, for example, the engager element 2431 is aligned withand/or engages the plate engager 147, thereby securing the interbodydevice 240 to the cage 102 to form the interbody system 300.

FIGS. 16A-16C illustrate an example of implanting the interbody system300 between adjacent vertebrae 4. More specifically, FIG. 16Aillustrates a top or superior (or bottom or inferior) cross-sectionalview of the spine 2 (shown in FIG. 1) with the interbody system 300implanted; FIG. 16B shows a perspective anterior/coronal view of theimplanted interbody system 300; and, FIG. 16C shows a sagittal view ofthe implanted system 300.

The interbody system 300 may be configured for use in, for example,anterior approach and discectomy applications. The interbody system 300may be implanted between the vertebrae 4 in similar manner to thatdescribed above with reference to FIG. 14. That is, the patient may bepositioned in a supine position on, for example, a radiolucent operatingtable, the surgical area cleaned, an incision made, muscle tissue and/ororgans moved to the side(s), and other common surgical procedurescarried out. A disc may then be incised, removed, and the space preparedfor implanting of the interbody system 300. The bone surfaces and edgeson the adjacent vertebrae 4 may be carefully contoured, as appropriate.

Following the discectomy procedure, the medical professional maydetermine an appropriate size of the interbody system 300 by selectingan appropriately dimensioned interbody system 300, which may beselectable based on, for example, height, width, depth, surfaceangle(s), and the like. If the interbody device 240 and cage 102 areprovided separately, the medical professional may select an interbodydevice 240 having appropriate dimensions (such as height, width, depth,surface angles, and the like) for the particular procedure and patient'sanatomy, and the medical professional may similarly select a cage body102 having appropriate dimensions (such as height, width, depth, surfaceangles, and the like) for the procedure and patient's anatomy. Themedical professional may then assemble the interbody device 240 and cage102 to form the interbody system 300, as shown in FIG. 15E. The medicalprofessional may then place the interbody system 300 in the preparedspace between the vertebrae 4

Upon selecting the appropriate interbody system 300, one or more of anACIF, ALIF, or the like may be performed by placing the interbody system300 between adjacent vertebrae 4 in the space formed by the removeddegenerated disc (shown in FIGS. 16B and 16C). One or more fasteners 11may be installed using an instrument (not shown), such as, for example,a screw driver (not shown). As each fastener 11 is inserted through theaperture 242 and into contact with the wall membrane 162, the wallmembrane 162 may bend and provide directional support against theskyping due to the springboard effect of wanting to back into itsnatural state, thereby urging the fastener 11 to the anchoring site.Simultaneously, due to the pushing of the wall membrane 162 into thegraft chamber 150, the wall membrane may direct graft material from thegraft chamber 150 to the areas surrounding the interbody system 300.

After the fasteners 11 are implanted in their final positions in theanchoring sites, the locking element 247 may be turned or otherwisemanipulated to secure the fastener(s) 11 in place, thereby preventingthe fastener(s) 11 from backing out (e.g., unscrewing) and/or dislodgingfrom the anchor site(s).

Placement of the interbody system 300 within spinal column may preventspaces between adjacent vertebrae 4 from collapsing, thereby preventingadjacent vertebrae from resting immediately on top of one another andinducing fracture of vertebra 4, impingement of the spinal cord, and/orpain. Additionally, such interbody system 300 may facilitate fusion(e.g., bone to grow together) between adjacent vertebrae 4 bystabilizing adjacent vertebrae 4 relative to one another.

FIG. 17A illustrates another example of an interbody device 410. Theinterbody device 410 may include the anterior coronal (or front) face401 and a posterior coronal (or back face, not shown) defining aplurality (e.g., four) apertures 242 therebetween. The interbody device410 may include one or more (e.g., two) locking elements 247.

The interbody device 410 may include a window 415. The window 415 mayprovide access and/or visibility to the space behind the back face (notshown) of the interface device 410. The window 415 may remain emptyand/or may be filled with radiolucent material such as tissue grafts.The window 415 may enable a medical professional to view and/ordetermine the level of post-operative fusion between interbody device410 and patient bone and/or tissue. The window 415 may be generallyquadrilateral (e.g., square, rectangular, or trapezoidal). In somearrangements, a radiolucent structure, such as a graft containmentsheath, may be disposed over the window. Indeed, such graft containmentsheaths may substantially fill or encompass the window 244. Accordingly,when the interbody device 410 is placed between two adjacent vertebrae 4under X-ray vision, window 415 remains radiolucent such that fusionwithin and/or through window 415 may be observed.

The interbody device 410 may include one or more (e.g., two) toolinterfaces 414. The tool interfaces may be configured to be grasped by,attach to, or otherwise be contacted and engaged by a tool (not shown)during a medical implant procedure.

The interbody device 410 may be formed as a single piece (not shown), orit may be assembled from two or more pieces, such as, for example theframe 413 and a pair of the locking elements 247.

The body or frame 413 of the interbody device 410 may includeanti-migration and/or anchoring features 4132. The features 4132 may beconfigured to contact and engage surface portions of, for example, thecage 102 (shown in FIGS. 17B-17E) to secure the interbody device 410 tothe cage. The features 4132 may be configured to assist in aligning andproper positioning of the interbody device 410 with respect to the cage102 in a manner similar to that described above with respect to theinterbody device 240 and cage 102 (shown in FIG. 15E). The features 4132may be configured similar to or substantially the same as the features2432 described above.

The frame 413 may include anti-migration and/or anchoring features (notshown) located on upper and/or lower surfaces of the interbody device410 to contact and engage adjacent bone surface(s). The features maycomprise, for example, a pattern and/or texture that providesanti-migration and/or anchoring characteristics when implanted in thespine 2. The features may comprise, e.g., teeth, serrations, protrusions(e.g., triangular, pyramidal, conical, semi spherical, quadrilateral,rectangular, cylindrical, diamond, elliptical, and/or irregular shapes,or the like), or the like.

The frame 413 may include a channel (not shown) similar to the channel2433 shown in FIGS. 13A and 13C. The channel may be provided on one orboth inner walls of the frame 413. The channel may be configured toreceive, engage and guide the plate guide 146 of cage 102 (shown in FIG.4) in a manner similar to or substantially the same as the channel 2432described above, thereby providing proper alignment and positioning ofthe interbody device 410 with respect to the cage (e.g., shown in FIG.17B).

As noted previously, the locking element 247 may be similar inconstruction and manner of use as described, for example, in FIG.3A-22D, 33, 35, 37, 39, 55, 58-65B, or 69A-78E and the correspondingtext in U.S. patent application Ser. No. 14/956,084, filed Dec. 1, 2015,titled “Intervertebral Implants and Related Systems and Methods,” whichhas been incorporated herein by reference. Further, various arrangementsof interbody device 410 may include one or more features configured tofacilitate sagittal and/or coronal visibility. For example, the body orframe 413 of interbody device 410 may comprise a radiopaque materialvisible via x-ray or similar forms of imaging modalities. As such, frame413 may enable accurate positioning and/or placement of interbody device410 within and/or along spinal column 2 (shown in FIG. 1).

The interbody device 410 may further include an engager element 2431 onat least one side of the frame 413, which may function in the mannerdescribed above with references to FIGS. 13A and 13B. The engagerelement 4131 may function in the same manner as the engager element2431.

The interbody device 410 may be implanted in a manner similar to thatdescribed above for interbody device 240, with references to FIGS.13A-13C and 14. The interbody device 410 may be configured for use in,for example, anterior approach and discectomy applications

FIGS. 17B-17E illustrate various views of an example of an interbodysystem 400 that includes the interbody device 410. As seen, theinterbody system 400 includes the interbody device 410 and the cage 102(shown in FIG. 4). The interbody system 400 may be formed as a singlestructure (not shown), or it may be assembled from two or more pieces.

For instance, referring to FIG. 17B, the interbody system 400 may beassembled by attaching the interbody device 410 to the cage 102 (or cage101, shown in FIG. 3). In this regard, the interbody device 410 may beassembled in a manner similar to or substantially the same as thatdescribed above with references to FIG. 15E for the interbody system300.

FIG. 17C shows an example of the interbody system 400 with the lockingelements 247 positioned in a locking or near-locking position. As seen,a portion of the locking elements 247 is turned and positioned in theaperture(s) 242, thereby partially (or entirely) blocking theaperture(s) 242, so that the bone fastener 11 (shown in FIG. 18B) isprevented from backing out of the aperture 242.

FIG. 17D shows a superior (or inferior) view of the interbody system400.

FIG. 17E shows a sagittal view of the interbody system 400.

FIGS. 18A-18C illustrate an example of implanting the interbody system400 between a pair of bony structures (e.g., vertebrae) 4.

Referring to FIGS. 17B-17E and 18A-18C simultaneously, the interbodysystem 400 may be configured for use in, for example, anterior approachand discectomy applications. For instance, after a patient is positionedin a supine position on, for example, a radiolucent operating table, thesurgical area cleaned, an incision made, muscle tissue and/or organsmoved to the side(s), and other common surgical procedures carried out,a disc may be incised, removed, and the space prepared for implanting ofan interbody system 400. The bone surfaces and edges on the adjacentvertebrae 4 may be carefully contoured, as appropriate.

Following a discectomy procedure, a medical professional may determinean appropriate size of the interbody device 410 and/or the cage 102 (or101) by selecting an appropriately dimensioned interbody device 410and/or an appropriately dimensioned cage 102 (or 101), each of which maybe selectable based on, for example, height, width, depth, surfaceangle(s), and the like. Where the interbody system 400 is provided as asingle unit, the interbody system 400 as a unit may be selected based onits dimensions for the particular application.

Upon selecting the appropriate interbody system 400 (e.g. interbodydevice 410 and cage 102), one or more of an ACIF, ALIF, or the like maybe performed by placing the interbody system 400 between adjacentvertebrae 4 in the space formed by the removed degenerated disc (shownin FIGS. 18A-18C). The medical professional may then place the cageportion of the interbody system 400 in the space between the vertebrae4. The medical professional may prepare the coronal surfaces of theadjacent vertebrae 4 by removing bone material to substantially matchthe outer perimeter of the interbody device 410, so as to receive atleast a portion of the interbody device 410 in the prepared areas on thevertebrae 4 and thereby position the anterior coronal face 401 of theinterbody device 410 (shown in FIG. 17A) substantially flush with theanterior coronal surfaces of the adjacent vertebrae 4.

Once the interbody system 400 is seated in its final position, four bonefasteners 11 may be installed using an instrument (not shown), such as,for example, a screw driver (not shown). As each fastener 11 is insertedthrough the aperture 242 and into contact with the wall membrane 162,the wall membrane 162 may bend and provide directional support againstthe skyping due to the springboard effect of wanting to back into itsnatural state. Simultaneously, due to the pushing of the wall membrane162 into the graft chamber 150, the wall membrane may direct graftmaterial from the graft chamber 150 to the areas surrounding theinterbody system 400.

After the fasteners 11 are implanted in their final positions in theanchoring sites, the locking element 247 may then be turned or otherwisemanipulated to secure the fasteners 11 in place, thereby preventing thefasteners 11 from loosening or withdrawing from their respectiveanchoring sites.

After the bone graft materials are installed, and the bone fasteners 11are securely and properly placed, and the installation of the interbodysystem 400 (or 300) completed, the area may be cleaned, checked, closedand other post-operative procedures carried out, as is known in the art.

Placement of the interbody system 400 within spinal column may preventspaces between adjacent vertebrae 4 from collapsing, thereby preventingadjacent vertebrae from resting immediately on top of one another andinducing fracture of vertebra 4, impingement of the spinal cord, and/orpain. Additionally, such interbody system 400 may facilitate fusion(e.g., bone to grow together) between adjacent vertebrae 4 bystabilizing adjacent vertebrae 4 relative to one another.

In the instant disclosure, where the fastener 11 includes a bone screw,a thread may be tapped into the bone to form a tap (not shown) toreceive and securely hold the bone fastener 11. The process would berepeated for each fastener 11. Such holes may be formed with the aid ofa separate drill guide (not shown) positioned proximate or abuttingvertebra 4 and inserting a drill therethrough. Alternatively, such holesmay be formed free hand, without the use of a drill guide.

After the interbody device or interbody system is properly installedwith respect to the vertebrae 4 (e.g., as shown in FIG. 14, 16A-16C or18A-18C), the bone fastener(s) 11 may be installed. In this regard, adriver tool (not shown), as is known by those skilled in the art, may beused to turn and drive the bone fastener(s) 11 into the vertebrae 4. Itis noted that the bone fastener(s) 11 may be aligned with the tap (notshown) in the bone and screwed into the threaded tap. Alternatively, thebone fasteners 11 may be partially installed in the tap before beingcontacted by the driver tool. Once the bone fasteners 11 are implantedin the desired position, the driver tool may be removed and the processrepeated for each bone fastener 11.

The terms “including,” “comprising,” and variations thereof, as used inthis disclosure, mean “including, but not limited to,” unless expresslyspecified otherwise.

The terms “a,” “an,” and “the,” as used in this disclosure, means “oneor more,” unless expressly specified otherwise.

Devices that are in communication with each other need not be incontinuous communication with each other, unless expressly specifiedotherwise. In addition, devices that are in communication with eachother may communicate directly or indirectly through one or moreintermediaries.

Although process steps, method steps, or the like, may be described in asequential order, such processes and methods may be configured to workin alternate orders. In other words, any sequence or order of steps thatmay be described does not necessarily indicate a requirement that thesteps be performed in that order. The steps of the processes or methodsdescribed herein may be performed in any order practical. Further, somesteps may be performed simultaneously.

When a single device or article is described herein, it will be readilyapparent that more than one device or article may be used in place of asingle device or article. Similarly, where more than one device orarticle is described herein, it will be readily apparent that a singledevice or article may be used in place of the more than one device orarticle. The functionality or the features of a device may bealternatively embodied by one or more other devices which are notexplicitly described as having such functionality or features.

While the disclosure has been described in terms of exemplaryembodiments, those skilled in the art will recognize that the disclosurecan be practiced with modifications in the spirit and scope of theappended claims. These examples are merely illustrative and are notmeant to be an exhaustive list of all possible designs, embodiments,applications or modifications of the disclosure.

What is claimed is:
 1. An interbody system for implanting betweenvertebrae, comprising a cage body that includes a pair of sagittalwalls, an aft-wall and a wall membrane that is made of a shape memoryform material; and an interbody device that attaches to the cage body,wherein the interbody device comprises an aperture that receives a bonefastener, and wherein the wall membrane bends under a force applied bythe bone fastener.
 2. An interbody system for implanting betweenvertebrae, comprising: a cage having a cage body that includes a graftchamber having a volume that receives graft material, a sagittal wallthat forms a portion of the graft chamber, and a wall membrane thatforms another portion of the graft chamber, wherein the wall membraneinteracts with a bone fastener.
 3. The interbody system of claim 2,wherein the wall membrane interacts with the bone fastener to bend asresult of a force applied by the bone fastener to a portion of the wallmembrane, thereby providing directional support to the bone fastener. 4.The interbody system of claim 2, wherein the wall membrane interactswith the bone fastener to bend as result of a force applied by the bonefastener to reduce the volume of the graft chamber, thereby forcinggraft material from the graft chamber.
 5. The interbody system of claim2, the system further comprising: an interbody device that includes anaperture that receives the bone fastener, wherein the wall membranecomprises a slit.
 6. The interbody system of claim 5, wherein the slitfacilitates bending of a portion of the wall membrane as a result of aforce applied to said portion of the wall membrane.
 7. An interbodysystem for implanting between vertebrae, comprising: a cage having acage body that includes a graft chamber having a volume that receivesgraft material, a first sagittal wall having an inner wall surface thatforms a first sagittal portion of the graft chamber, a second sagittalwall having an inner wall surface that forms a second sagittal portionof the graft chamber, an aft-wall having an inner wall surface thatforms a posterior coronal portion of the graft chamber, and a wallmembrane that forms an anterior coronal portion of the graft chamber;and an interbody device that includes an aperture that receives a bonefastener, wherein the wall membrane interacts with the bone fastener. 8.The interbody system of claim 7, wherein the wall membrane interactswith the bone fastener to bend as result of a force applied by the bonefastener to a portion of the wall membrane, thereby providingdirectional support to the bone fastener.
 9. The interbody system ofclaim 7, wherein the wall membrane interacts with the bone fastener tobend as result of a force applied by the bone fastener to reduce thevolume of the graft chamber, thereby forcing graft material from thegraft chamber.
 10. The interbody system of claim 7, wherein the wallmembrane comprises a slit.
 11. The interbody system of claim 10, whereinthe slit facilitates bending of a portion of the wall membrane as aresult of a force applied to said portion of the wall membrane.
 12. Theinterbody system of claim 10, wherein the slit receives and guides thebone fastener.
 13. The interbody system of claim 7, wherein the wallmembrane comprises: a thin sheet that is integrated with or attached tothe cage body; a thin mesh that is integrated with or attached to thecage body; a thin screen that is integrated with or attached to the cagebody; or a beams screen that is integrated with or attached to the cagebody.
 14. The interbody system of claim 7, wherein the sagittal wallcomprises a recessed wall portion located proximate to the wallmembrane.
 15. The interbody system of claim 7, wherein the graft chambercomprises: a first chamber width portion that holds graft material; anda second chamber width portion that holds graft material, wherein thewidth of the first chamber width portion is greater than the width ofthe second chamber width portion.
 16. The interbody system of claim 7,wherein the sagittal wall comprises a grip interface that contacts andengages a grip interface provided on the interbody device to secure thecage to the interbody device.
 17. The interbody system of claim 7,wherein the interbody device comprises two or more apertures thatreceive two or more respective bone screws.
 18. The interbody system ofclaim 7, wherein the cage body comprises a plate guide that engages acage guide provided on the interbody device to facilitate properpositioning and alignment of the cage with respect to the interbodydevice.
 19. The interbody system of claim 7, wherein the cage bodycomprises a plate engager that aligns with a cage engager provided onthe interbody device to secure the cage body to the interbody device.